Non Small Cell Lung CancerPhase 3NCT01379976
Acetyl-L-carnitine in Combination With a Cisplatin-containing Chemotherapy as First Line Treatment of Advanced or Metastatic Non Small Cell Lung Cancer
A Phase 3 study testing Acetylcarnitine in people with Non Small Cell Lung Cancer, run by Mario Negri Institute for Pharmacological Research at 21 sites in Italy.
Trial summary
Study objectives Primary: To compare toxicity free survival of patients treated with ALC (acetylcarnitine) plus cisplatin-containing chemotherapy (CHT) versus those treated with placebo plus cisplatin-containing chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Acetylcarnitine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 21 sitesItaly
- Study dates
- Apr 2011to Oct 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18
- No previous CHT or targeted therapies. Previous adjuvant or neo-adjuvant treatment is permitted if completed ≥ 6 months before study inclusion.
- ECOG performance status 0-1
- Adequate organ functions defined as follows:
- Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL
- Bilirubin level either normal or < 1.5 x ULN
Show all 9Show fewer
- ASAT and ALAT < 2.5 x ULN (< 5 x ULN if liver metastasis are present)
- Serum creatinine <1.5 x ULN
- Written informed consent given before the randomization, according to International Conference on Harmonization/Good Clinical Practice (ICH/GCP)
Who cannot join
- Symptomatic brain metastases
- Any investigational agent(s) within 4 weeks prior to study entry
- Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
- Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
- Patients with known allergy to any other components of the study drugs
- History or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complication
Show all 13Show fewer
- Known drug abuse/ alcohol abuse
- Legal incapacity or limited legal capacity
- Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
- Clinically relevant peripheral neuropathy
- Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix (Patients with a previous malignancy but without evidence of disease for < 5 years will be allowed to enter the trial)
- Pregnancy or breast feeding. Women of childbearing potential and their parents must be willing to practice acceptable methods of birth control to prevent pregnancy
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Italy21 sites
Azienda Ospedaliera Ospedale S. Anna
Como, 22020
Azienda Ospedaliera Istituti Ospitalieri
Cremona, 26100
Azienda Ospedaliera di Desio e Vimercate - Presidio Ospedaliero di Desio
Desio, 20832
Ospedale Civile
Guastalla, 42016
Ospedale Alessandro Manzoni
Lecco, 23900
Azienda Ospedaliera Ospedale Civile di Legnano
Legnano, 20025
Azienda Ospedaliera Fatebenefratelli e Oftalmico
Milan, 20121
Istituto Europeo Di Oncologia
Milan, 20141
Azienda Ospedaliera San Paolo
Milan, 20142
Azienda Ospedaliera Ospedale San Carlo Borromeo
Milan, 20153
Azienda Ospedaliero Universitaria di Parma
Parma, 43126
Fondazione Salvatore Maugeri
Pavia, 0381 33329
Azienda Ospedaliera Perugia
Perugia, 06075
Arcispedale S. Maria Nuova
Reggio Emilia, 42100
IRCCS di Reggio Emilia
Reggio Emilia, 42123
Azienda Ospedaliera Busto Arsizio - Presidio Ospedaliero di Saronno
Saronno, 21047
Ospedale SS Annunziata - ASL1
Sassari, 07100
Azienda Ospedaliera Valtellina e Valchiavenna , Presidio Ospedaliero di Sondrio
Sondrio, 23100
Istituto Oncologico del Mediterraneo
Viagrande, CT, 95029
Azienda Ospedaliera di Pavia, Ospedale Civile di Vigevano
Vigevano, 27029
Azienda Ospedaliera di Desio e Vimercate - Presidio Ospedaliero di Vimercate
Vimercate, 20059
About this study
Official title: Randomized, Double-blind, Placebo-controlled Phase 3 Trial to Assess the Efficacy and Safety of Acetyl-L-carnitine in Combination With a Cisplatin-containing Chemotherapy as First Line Treatment of Advanced or Metastatic Non Small Cell Lung Cancer
Study objectives Primary: To compare toxicity free survival of patients treated with ALC (acetylcarnitine) plus cisplatin-containing chemotherapy (CHT) versus those treated with placebo plus cisplatin-containing chemotherapy.
Secondary: To compare progression free survival, overall survival, the compliance to treatment, the number of episodes of grade 3-4 National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0, neurotoxicity, as well as the proportion of patients experiencing grade 2-3-4 National Cancer Institute Common Terminology Criteria for Adverse Events, neuropathic pain intensity, the clinical signs and/or symptoms (such as burning, numbness, itching, etc.) of the sensorial neuropathy between the two treatment arms. Study design Multicentre, randomised, double-blind, placebo-controlled, phase III, superiority study in patients with advanced or metastatic NSCLC (non small cell lung cancer).
Read more
Patients to be screened for study inclusion are those for which the decision to start a cisplatin-containing treatment has been already taken in the context of the clinical practice. The type of cisplatin-based treatment is not fixed, but each single investigator is free to choose for each single patient among those already approved for first line treatment of advanced or metastatic NSCLC.
Patients meeting the eligibility criteria will be randomized with a 1 : 1 ratio to receive ALC + cisplatin-containing CHT or Placebo + cisplatin-containing CHT until patient refusal, disease progression, unacceptable toxicity or death. The study will be conducted in Italy in approximately 20 investigational centers in order to recruit 650-675 subjects over a 30-month period.
Both efficacy and safety data will be collected. Follow-up will be according to the clinical practice. Data capture will continue, for each patient, until death or study closure.
Read the detailed description
Inclusion criteria:
- Male or female >= 18
- No previous CHT or targeted therapies. Previous adjuvant or neo-adjuvant treatment is permitted if completed ≥ 6 months before study inclusion.
- ECOG performance status 0-1
- Adequate organ functions defined as follows:
- Neutrophils >= 1.5 x 109/L, platelets >= 100 x 109/L, and hemoglobin >= 9 g/dL
- Bilirubin level either normal or < 1.5 x ULN
- ASAT and ALAT <= 2.5 x ULN (<= 5 x ULN if liver metastasis are present)
- Serum creatinine <1.5 x ULN
- Written informed consent given before the randomization, according to International Conference on Harmonization/Good Clinical Practice (ICH/GCP)
Exclusion criteria:
- Symptomatic brain metastases
- Any investigational agent(s) within 4 weeks prior to study entry
- Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
- Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
- Patients with known allergy to any other components of the study drugs
- History or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complication
- Known drug abuse/ alcohol abuse
- Legal incapacity or limited legal capacity
- Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
- Clinically relevant peripheral neuropathy
- Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix (Patients with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial)
- Pregnancy or breast feeding. Women of childbearing potential and their parents must be willing to practice acceptable methods of birth control to prevent pregnancy
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Acetylcarnitine, Placebo
- Keywords
- lung, cancer, non small cell lung cancer, Advanced or metastatic non small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetylcarnitineDrug
Also called ST 200
ALC or placebo will be administered concurrently with CHT at 1000 mg sachet three times every day (before meals).
Treatment should be administered for a maximum of 6 cycles for both arms unless progression or unacceptable toxicity, or treatment refusal.
PlaceboDrug
ALC or placebo will be administered concurrently with CHT at 1000 mg sachet three times every day (before meals).
Treatment should be administered for a maximum of 6 cycles for both arms unless progression or unacceptable toxicity, or treatment refusal.
| Study group | Role | What they receive |
|---|---|---|
| CHT cisplatin containing + placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| CHT cisplatin containing + acetyl-L-carnitina | Experimental | Not described Receives: Drug: Acetylcarnitine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity Free Survival
The primary efficacy endpoint is toxicity-free survival, defined as the time from randomisation up to the occurrence of related to treatment grade 2-3-4 NCI-CTCAE neurotoxicity, progression, second primary malignancy, death from any cause, whichever comes first. Subjects who have not experienced related to treatment grade 2-3-4 toxicity, and not progressed or died while on study will be censored at their last assessment date.
Measured: participants will be followed for the duration of chemotherapy and for at least 1 yaer after the completation of treatment, an expected average of 18 months
Secondary outcomes (3)
Progression-free survival
defined as the time from randomisation up to the occurrence of progression, second primary malignancy, death from any cause, whichever comes first. Subjects who have not progressed or died while on study will be censored at their last assessment date
Measured: participants will be followed for the duration of chemotherapy and for at least 1 yaer after the completation of treatment, an expected average of 18 months
Overall survival
defined as the time from the date of randomisation to the date of death from any cause. Subjects not reported as having died at the end of the study will be censored at the date they were last known to be alive
Measured: participants will be followed for the duration of chemotherapy and for at least 1 yaer after the completation of treatment, an expected average of 18 months
Neuropathic pain
Occurrence of neuropathic pain is defined as the presence of at least 4 of the 10 clinical signs/symptoms listed in the DN4-Questionnaire Neuropathic pain intensity is defined as the intensity of pain reported by patients (current, average and worst during the last week) during scheduled visit as assessed by a self-administered questionnaire (BPI)
Measured: participants will be followed for the duration of chemotherapy and for at least 1 yaer after the completation of treatment, an expected average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Recruitment was prematurely stopped due to difficulty of recruitment encountered by the experimental centers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucio Crinò, MD, Principal investigator, Azienda Ospedaliera di Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379976
- Sponsor's protocol ID
- 2010-022021-15
- Status last verified
- Jul 2014
- First submitted
- 16 Jun 2011
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Phase 3 Trial to Assess the Efficacy and Safety of Acetyl-L-carnitine in Combination With a Cisplatin-containing Chemotherapy as First Line Treatment of Advanced or Metastatic Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01379976
- Acronym / sponsor ID
- 2010-022021-15
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- lung, cancer, non small cell lung cancer, Advanced or metastatic non small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was prematurely stopped due to difficulty of recruitment encountered by the experimental centers
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study objectives Primary: To compare toxicity free survival of patients treated with ALC (acetylcarnitine) plus cisplatin-containing chemotherapy (CHT) versus those treated with placebo plus cisplatin-containing chemotherapy.
Secondary: To compare progression free survival, overall survival, the compliance to treatment, the number of episodes of grade 3-4 National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0, neurotoxicity, as well as the proportion of patients experiencing grade 2-3-4 National Cancer Institute Common Terminology Criteria for Adverse Events, neuropathic pain intensity, the clinical signs and/or symptoms (such as burning, numbness, itching, etc.) of the sensorial neuropathy between the two treatment arms. Study design Multicentre, randomised, double-blind, placebo-controlled, phase III, superiority study in patients with advanced or metastatic NSCLC (non small cell lung cancer).
Patients to be screened for study inclusion are those for which the decision to start a cisplatin-containing treatment has been already taken in the context of the clinical practice. The type of cisplatin-based treatment is not fixed, but each single investigator is free to choose for each single patient among those already approved for first line treatment of advanced or metastatic NSCLC.
Patients meeting the eligibility criteria will be randomized with a 1 : 1 ratio to receive ALC + cisplatin-containing CHT or Placebo + cisplatin-containing CHT until patient refusal, disease progression, unacceptable toxicity or death. The study will be conducted in Italy in approximately 20 investigational centers in order to recruit 650-675 subjects over a 30-month period.
Both efficacy and safety data will be collected. Follow-up will be according to the clinical practice. Data capture will continue, for each patient, until death or study closure.
Detailed description
Inclusion criteria:
- Male or female >= 18
- No previous CHT or targeted therapies. Previous adjuvant or neo-adjuvant treatment is permitted if completed ≥ 6 months before study inclusion.
- ECOG performance status 0-1
- Adequate organ functions defined as follows:
- Neutrophils >= 1.5 x 109/L, platelets >= 100 x 109/L, and hemoglobin >= 9 g/dL
- Bilirubin level either normal or < 1.5 x ULN
- ASAT and ALAT <= 2.5 x ULN (<= 5 x ULN if liver metastasis are present)
- Serum creatinine <1.5 x ULN
- Written informed consent given before the randomization, according to International Conference on Harmonization/Good Clinical Practice (ICH/GCP)
Exclusion criteria:
- Symptomatic brain metastases
- Any investigational agent(s) within 4 weeks prior to study entry
- Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
- Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
- Patients with known allergy to any other components of the study drugs
- History or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complication
- Known drug abuse/ alcohol abuse
- Legal incapacity or limited legal capacity
- Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
- Clinically relevant peripheral neuropathy
- Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix (Patients with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial)
- Pregnancy or breast feeding. Women of childbearing potential and their parents must be willing to practice acceptable methods of birth control to prevent pregnancy
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHT cisplatin containing + placebo | Placebo comparator | Drug: Placebo |
| CHT cisplatin containing + acetyl-L-carnitina | Experimental | Drug: Acetylcarnitine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female ≥ 18
- No previous CHT or targeted therapies. Previous adjuvant or neo-adjuvant treatment is permitted if completed ≥ 6 months before study inclusion.
- ECOG performance status 0-1
- Adequate organ functions defined as follows:
- Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL
Key exclusion criteria (13 listed)
- Symptomatic brain metastases
- Any investigational agent(s) within 4 weeks prior to study entry
- Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
- Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
- Patients with known allergy to any other components of the study drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetylcarnitineAlso: ST 200ALC or placebo will be administered concurrently with CHT at 1000 mg sachet three times every day (before meals). Treatment should be administered for a maximum of 6 cycles for both arms unless progression or unacceptable toxicity, or treatment refusal. | Drug | CHT cisplatin containing + acetyl-L-carnitina |
| PlaceboALC or placebo will be administered concurrently with CHT at 1000 mg sachet three times every day (before meals). Treatment should be administered for a maximum of 6 cycles for both arms unless progression or unacceptable toxicity, or treatment refusal. | Drug | CHT cisplatin containing + placebo |
Primary outcome
Toxicity Free Survival
Time frame: participants will be followed for the duration of chemotherapy and for at least 1 yaer after the completation of treatment, an expected average of 18 months
The primary efficacy endpoint is toxicity-free survival, defined as the time from randomisation up to the occurrence of related to treatment grade 2-3-4 NCI-CTCAE neurotoxicity, progression, second primary malignancy, death from any cause, whichever comes first. Subjects who have not experienced related to treatment grade 2-3-4 toxicity, and not progressed or died while on study will be censored at their last assessment date.
3 secondary outcomes
Progression-free survival
Time frame: participants will be followed for the duration of chemotherapy and for at least 1 yaer after the completation of treatment, an expected average of 18 months
Overall survival
Time frame: participants will be followed for the duration of chemotherapy and for at least 1 yaer after the completation of treatment, an expected average of 18 months
Neuropathic pain
Time frame: participants will be followed for the duration of chemotherapy and for at least 1 yaer after the completation of treatment, an expected average of 18 months
Results and safety
The study was stopped early (reason given: Recruitment was prematurely stopped due to difficulty of recruitment encountered by the experimental centers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucio Crinò, MD principal investigator
Azienda Ospedaliera di Perugia
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetylcarnitine in people with Non Small Cell Lung Cancer, run by Mario Negri Institute for Pharmacological Research at 21 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment was prematurely stopped due to difficulty of recruitment encountered by the experimental centers). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity Free Survival (time frame: participants will be followed for the duration of chemotherapy and for at least 1 yaer after the completation of treatment, an expected average of 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015.